Youtor
Chromatin Biology Epigenetics and the Regulation of Gene Activity
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=ig3jvpqYKrM
FDA discusses the preclinical program to inform early clinical development for cell and gene therapy (CGT) products; including considerations for relevant animal models, assessments for proof-of-concept, safety, biodistribution to support first-in-human studies, and pathways of early communication with FDA and CBER. • Presenter: • Ying Huang, Ph.D., Pharmacology/Toxicology Reviewer, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissues and Advanced Therapies (OTAT), CBER • Learn more at: https://www.fda.gov/drugs/news-events... • -------------------- • FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products clinical research. • Upcoming Training - https://www.fda.gov/cdersbia • SBIA Listserv - https://public.govdelivery.com/accoun... • SBIA 2021 Playlist - • 2021 CDER Small Business and Industry... • SBIA LinkedIn - / cder-small-business-and-industry-assistance • SBIA Training Resources - https://www.fda.gov/cderbsbialearn • Twitter - / fda_drug_info • Email - [email protected] • Phone - (301) 796-6707 I (866) 405-5367
#############################
